BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM PLUS CEEA

    MDR report key: 1891129 · Received October 17, 2010

    Report

    Report Number
    1891129
    Event Type
    Malfunction
    Date Received
    October 17, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 17, 2010
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDO-RECTAL PULL THROUGH SURGERY, THE TEAM USED THE CEEA 31MM AUTOSUTURE STAPLER. PART OF THE STAPLER DID NOT FIRE THE WHOLE CIRCUMFERNETIAL LOAD. THE DEVICE DID NOT WORK PROPERLY, IT WAS THEN CAREFULLY REMOVED BY THE ATTENDING SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA STAPLER, SURGICAL GDW COVIDIEN * P0B0752J

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR